2019-nCoV Antigen Rapid Test Uncut Sheet
This product is used for in vitro qualitative detection of the antigen of novel coronavirus in human nasal swabs. The novel coronaviruses belong to the β genus.
Product Overview
Product Parameters
| Parameter | Specification |
|---|---|
| Code | RUCV5 |
| Specimen | Human nasal swab |
| Format | Rapid Test Uncut Sheet |
This product is used for in vitro qualitative detection of the antigen of novel coronavirus in human nasal swabs. The novel coronaviruses belong to the β genus. COVID-19 is an acute respiratory infectious disease. People are generally susceptible. Currently, the patients infected by the novel coronavirus are the main source of infection; asymptomatic infected people can also be an infectious source. Based on the current epidemiological investigation, the incubation period is 1 to 14 days, mostly 3 to 7 days. The main manifestations include fever, fatigue and dry cough. Nasal congestion, runny nose, sore throat, myalgia and diarrhea are found in a few cases.
Assay Information
Test principle
This kit uses immunochromatography for detection. The specimen will move forward along the test card under capillary action. If the specimen contains a novel coronavirus antigen, the antibody will bind to the colloidal gold-labeled new coronavirus monoclonal antibody. The immune complex will be membrane fixed will be coronavirus monoclonal antibody capture, form the fuchsia line, display will be coronavirus antigen positive;If the line does not show color, the negative result will be displayed. The test card also contains a quality control line C, which shall appear fuchsia regardless of whether there is a detection line.
Main components
1 Nasal swab
2 Antigen extraction tube (with cap)
3 Antigen extraction buffer
4 Test card
Storage conditions & period of validity
1 Store at 4℃~30℃, and it is valid for 24 months.
2 After the aluminum foil bag is unsealed, the test card should be used as soon as possible within one hour.
Specimen request
Let the patient's head relax naturally, and slowly rotate the swab against the wall of the nostril into the patient's nostril to the nasal palate, and then slowly remove it while wiping. Using the same swab, wipe the other nostril in the same way; place the swab specimen in the extraction tube with the extraction solution added in advance, rotate the swab for about 10 seconds, and press the swab head against the tube wall to release the swab antigen.
Test methods
The test method was colloidal gold. Please read the manual and the instrument operation manual carefully before use.
Operation method
1. Open the foil pouch package and take out the test card.
2. Place the extraction tube on the workbench. The swab extractor bottle is pressed vertically downward to allow the solution to drip freely into the extractor tube without touching the edge of the tube. Add 6 drops (approximately 200ul) of extraction buffer to the extraction tube.
3. Put the swab specimen into the extraction tube, rotate the swab for about 10 times, and press the swab head against the tube wall to release the antigen in the swab. Squeeze the swab over the head to remove the swab so as to remove as much liquid as possible from the swab. Dispose of swabs according to biohazard waste disposal method.
4. Install the dropper cap on the extraction tube and leave for 1 minute, then put three drops into the specimen hole of the test card, start the timer.
5. Read the results at 15 minutes, and the results after 30 minutes are no longer valid.
Interpretation of test results
Negative result: if there is only a quality control line C, the detection line is colorless, indicating that novel coronavirus antigen has not been detected and the result is negative.
Positive result: if both the quality control line C and the detection line appear, novel coronavirus antigen has been detected and the result is positive for antigen.
Invalid result: if the quality control line C is not observed, it will be invalid regardless of whether there is detection line (as shown in the figure below), and the test shall be conducted again.
Limitations of inspection methods
1. This reagent is only used for in vitro diagnosis.
2. This reagent is only used to detect human nasal swab extracts. The results of other specimens may be wrong.
3. This reagent is only used for qualitative detection and cannot indicate the level of novel coronavirus antigen in the specimen.
4. This reagent is only a clinical auxiliary diagnostic tool. If the result is positive, it is recommended to use other methods for further examination in time and the doctor’s diagnosis shall prevail.
Precautions
1. Read the instructions carefully before using the kit, and strictly control the reaction time. If you do not follow the instructions, you will get inaccurate results.
2. The specimen shall be tested in a laboratory with certain conditions. All specimens and materials during testing should be handled in accordance with the laboratory practice for infectious diseases.
3. Guard against moisture, do not open the aluminum platinum bag before it is ready for testing. Do not use the aluminum foil bag when it is damaged or the test card is damp.
4. Please use it within the validity period.
5. Balance all reagents and specimens to room temperature (15 ~ 30 ℃) before use.
6. Do not replace the components in this kit with components in other kits.
7. Do not dilute the specimen for testing, otherwise you may get inaccurate results.
8. The kit shall be stored in strict accordance with the conditions specified in this manual. Please do not store the kit under freezing conditions.
9. The test methods and results must be interpreted in strict accordance with this specification.
10. Negative results will occur with this kit if the novel coronavirus antigen titer in the specimen falls below the minimum detection limit for this kit.